NDC Code(s) : 59762-2242-9, 59762-2242-3, 59762-2010-9, 59762-2010-3, 59762-2010-1, 59762-2135-9, 59762-2135-1
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

amlodipine besylateamlodipine besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-2242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE2.5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape DIAMOND Size 7 mm
Flavor Imprint Code NORVASC;2;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59762-2242-990 in 1 BOTTLE Type 0: Not a Combination Product24/06/2019
2NDC:59762-2242-3300 in 1 BOTTLE Type 0: Not a Combination Product24/06/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019787 06/24/2019
amlodipine besylateamlodipine besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-2010
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape OCTAGON (8 SIDED) (elongated octagon) Size 9 mm
Flavor Imprint Code NORVASC;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59762-2010-990 in 1 BOTTLE Type 0: Not a Combination Product24/06/2019
2NDC:59762-2010-3300 in 1 BOTTLE Type 0: Not a Combination Product24/06/2019
3NDC:59762-2010-11000 in 1 BOTTLE Type 0: Not a Combination Product24/06/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019787 06/24/2019
amlodipine besylateamlodipine besylate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-2135
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE(UNII: 864V2Q084H)
(AMLODIPINE - UNII:1J444QC288) 		AMLODIPINE10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(UNII: L11K75P92J)
SODIUM STARCH GLYCOLATE TYPE A(UNII: H8AV0SQX4D)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code NORVASC;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59762-2135-990 in 1 BOTTLE Type 0: Not a Combination Product24/06/2019
2NDC:59762-2135-11000 in 1 BOTTLE Type 0: Not a Combination Product13/11/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019787 06/24/2019

LABELER - Mylan Pharmaceuticals Inc.(059295980)

PRINCIPAL DISPLAY PANEL

NDC 59762-2242-9

90 Tablets

GREENSTONE ® BRAND

amlodipine
besylate
tablets

2.5 mg*

Rx only

Store at controlled room
temperature, 59° to 86°F
(15° to 30°C).

PROTECT FROM LIGHT.

Dispense in tight (USP),
light-resistant, child
resistant containers.

DOSAGE AND USE
See accompanying
prescribing information.
*Each tablet contains
amlodipine besylate
equivalent to 2.5 mg
amlodipine.

Distributed by:
Greenstone LLC
Morgantown, WV 26505 U.S.A.

© 2024 Viatris Inc.

RGST2242MM

2.5 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 59762-2010-9

90 Tablets

GREENSTONE ® BRAND

amlodipine
besylate
tablets

5 mg*

Rx only

Store at controlled room
temperature, 59° to 86°F
(15° to 30°C).

PROTECT FROM LIGHT.

Dispense in tight (USP),
light-resistant, child
resistant containers.

DOSAGE AND USE
See accompanying
prescribing information.
*Each tablet contains
amlodipine besylate
equivalent to 5 mg
amlodipine.

Distributed by:
Greenstone LLC
Morgantown, WV 26505 U.S.A.

© 2024 Viatris Inc.

RGST2010MM

5 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 59762-2135-9

90 Tablets

GREENSTONE ® BRAND

amlodipine
besylate
tablets

10 mg*

Rx only

Store at controlled room
temperature, 59° to 86°F
(15° to 30°C).

PROTECT FROM LIGHT.

Dispense in tight (USP),
light-resistant, child
resistant containers.

DOSAGE AND USE
See accompanying
prescribing information.
*Each tablet contains
amlodipine besylate
equivalent to 10 mg
amlodipine.

Distributed by:
Greenstone LLC
Morgantown, WV 26505 U.S.A.

© 2024 Viatris Inc.

RGST2135MM

10 mg Bottle Label